International safety notice
For two production lots of dental implants from an overseas manufacturer, the internal product was There have been reports of cases of divisions being replaced, Catalog number: 834711 (implant length 11.5 mm) is labeled as 834713 (implant length 13 mm). Catalog number: 834713 (implant length 13 mm) is labeled as 834711 (implant length 11.5 mm). It says that it may be packaged. All products imported into Japan are inspected upon receipt, but we completely deny that the products in the package have been replaced. Since we are unable to do so, we will voluntarily recall the affected products.
Japan / PMDA Recalls · JPN · Oct 15, 2021
Key facts
| Title | For two production lots of dental implants from an overseas manufacturer, the internal product was There have been reports of cases of divisions being replaced, Catalog number: 834711 (implant length 11.5 mm) is labeled as 834713 (implant length 13 mm). Catalog number: 834713 (implant length 13 mm) is labeled as 834711 (implant length 11.5 mm). It says that it may be packaged. All products imported into Japan are inspected upon receipt, but we completely deny that the products in the package have been replaced. Since we are unable to do so, we will voluntarily recall the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Dental endosseous implant material Brand name: Legacy HA implant |
| Manufacturer | Inpratex Co., Ltd. |
| Models | 166297, 001-834711, 001-834713, 166300 |
| Date | Oct 15, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1